hair dx female androgen sensitivity test - training presentation

1Monday, October 11, 2010

• DermaGenoma is a genetics dermatology company

• DermaGenoma develops therapeutic and diagnostic products based on an individual’s genetic makeup

• World-renowned genetic scientists

• World-renowned hair dermatologists

• Products sold in over 30 countries on 6 continents

About DermaGenoma


Overview

• Current product lines:

– AcneDX - antibiotic therapy response for Acne Vulgaris

– HairDX - screen and therapy response for Androgenetic Alopecia

– CelluliteDX - screen for moderate to severe cellulite (gynoid lipodystrophy)

– HerpesDX - screen for frequent herpes outbreaks

– PsoriasisDX - screen for Psoriatic Arthritis


Genetic Test to determine Androgen Sensitivity

• Women with high androgen sensitivity are likely to respond to anti-androgen therapy for the treatment of hair loss (AGA)

• Women with high androgen sensitivity are at an increased risk of developing androgenetic alopecia (AGA)

What is the HairDX Genetic Test?


Science - Androgen Sensitivity

• Androgens are the male sex hormones testosterone and dihydrotestosterone, which are found in smaller amounts in women

• Androgens bind to androgen receptors in cells

• Androgen receptor sensitivity is determined by the genetics of the androgen receptor

• Androgen receptor sensitivity determines the affect of androgens on hair loss and anti-androgen therapy


1 2 3 4 5

6 7 8 9 10 11 12

13 14 15 16 17 18

19 20 21 22 X Y

• Human cells contain 46 chromosomes (23 pairs)

• X and Y are sex chromosomes

• Women have two X chromosomes

• Men have one X and one Y chromosome

Science - Genetics


Science - Genetics

• Chromosomes are made up of DNA

• There are four DNA bases C, A, G and T

• Sets of three DNA bases, called codons, can encode amino acids, e.g., the CAG codon encodes the amino acid glutamine


Science - Androgen Receptor

• The androgen receptor (AR) gene is located on the X-chromosome

• Androgen sensitivity on the AR gene is determined by the number of CAG repeats

• Women have two differentially activated X-chromosomes; hence, the test determines the CAG repeat in the activated X-chromosome

• Patients with few CAG repeats have an increase in androgen receptor activity and therefore high androgen sensitivity

• Patients with many CAG repeats have a decrease in androgen receptor activity and therefore low androgen sensitivity


HairDX Clinical Study

• Pioneering clinical study conducted by Dr. Sharon Keene (2009-2010)

• Women received 1mg/day finasteride for 6 months

• Hair counts were used to measure finasteride response

• Responders had a CAG score <23.5 had approximately a +24% change in hair counts (gain hair)

• Non-responders had a CAG score ≥23.5 had approximately a -4% change in hair counts (lose hair)

• Replicated in an independent cohort


10

HairDX Clinical Study


The HairDX Female Androgen Sensitivity Test


The HairDX Test Kit - Content

• 4 cheek (buccal) swabs

• Return envelope

• Instruction sheet

• Patient information sheet

• Service Agreement - General Terms and Conditions

• Informed consent form


How is the Test Performed?

• The HairDX genetic test can be performed at home but we recommend to perform the test at your clinic

• The test uses a cheek swabs that looks like a small toothbrush

• Four swabs are included in the test kit to assure a sufficient amount of DNA is collected


You MUST followthe instruction sheet

included with theHairDX Test Kit



• Carefully take out the sterile swab

• Swab the inside cheek for 30 seconds

• Use 2 swabs for each side

• Use all 4 swabs included with the kit

Make sure clientdoes NOT eat or drink

anything, 1 hour before sample collection

NEVER touch the swab tip with your fingers



• Put each used sterile swab back in the container tube

• Place the container tubes in the included envelope

• Seal the envelope

NEVER touch the swab tip with your fingers



• Genetic analysis of patient samples typically takes 2 weeks

• The genetic analysis is performed at DermaGenoma labs, the results are made available through a secure electronic or via fax (U.S. domestic only)

The HairDX Test - Process


The HairDX Test - Timeline

+/- 1 Month

+/- 3 Weeks


• The sample collection procedure is safe

• The sample is shipped without any personal identification

• The DermaGenoma laboratory destroys all the samples after 30 days

• The DermaGenoma laboratory is CLIA and HIPAA compliant - highest US laboratory and privacy standards

Safety and Confidentiality


Shipping to DermaGenoma (International)

• Storage prior to shipping to DermaGenoma should be at +4 degrees celsius

• Shipping to DermaGenoma should be by FedEx

• Shipping in standard package expedited delivery (no ice)

• Label on package to receive from DermaGenoma


• Immediately mail after the sample is collected in prepaid postage bubble mailer provided in the test kit

Shipping to DermaGenoma (Domestic)


HairDX Sample Report - Positive


HairDX Sample Report - Negative


Contact Information and Q&A

United StatesPhone: +1 (949) 428-2140Fax: +1 (949) 428-2142Email: [email protected]

Europe, Middle East, AfricaPhone: +32 47 725 8515Fax: +32 1 153 3686Email: [email protected]

Asia, OceaniaPhone: + 81 80 56 86 06 03Fax: +1 (949) 428-2142Email: [email protected]


mailto:[email protected]




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